Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01580020
First received: April 16, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 and CRFB002EDE18.


Condition Intervention Phase
Retinal Vein Occlusion
Biological: RFB002
Drug: Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, 6-month Extension Study Comparing the Long-term Efficacy and Safety of Lucentis (Ranibizumab) Intravitreal Injections Versus Ozurdex (Dexamethasone) Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) Who Have Completed the Respective Core Study (CRFB002EDE17 or CRFB002EDE18)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Collection of all ocular and non-ocular adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety assessments will consist of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), ophthalmic examinations, evaluation of cataract formation, intraocular pressure by tonometry, vital signs, and routine laboratory parameters.


Secondary Outcome Measures:
  • Collection of ocular and non-ocular adverse events of both treatment arms [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    • To describe and compare the ocular and non-ocular adverse events over a cumulative 15-months period - including the core and extension study - in patients treated with Lucentis vs. Ozurdex

  • Mean average change of best corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • To compare the mean average change of the best-corrected visual acuity (BCVA) assessed by ETDRS chart over the 6-months study period in patients treated with Lucentis vs. Ozurdex

  • Mean average change of best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    + To compare the mean average change of the best-corrected visual acuity (BCVA) assessed by ETDRS chart over 12-months study period- including the core and the extension study in patients treated with Lucentis. Ozurdex

  • Mean change in central subfield thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • To compare the mean change in central subfield thickness (CSFT) as assessed by OCT over the 6-months study period in patients treated with Lucentis vs. Ozurdex

  • Mean change in central subfield thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • To compare the mean change in central subfield thickness (CSFT) as assessed by OCT over the 12-months study period in patients treated with Lucentis vs. Ozurdex

  • Change of patients´ Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • To compare changes in the quality of life according to NEI-VFQ 25, SF36 and EQ-5D questionnaires under treatment of ranibizumab versus Ozurdex® from Baseline to Month 6

  • Time to the first retreatment and the total number of treatments of both treatment arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • To evaluate the time to the first retreatment and the total number of treatments for both Lucentis PRN and Ozurdex


Enrollment: 175
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A

The PRN injection scheme applied in the core study will also be followed during this extension study:

Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month

Biological: RFB002
Active Comparator: Arm B
A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.
Drug: Dexamethasone
Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone;

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively

Exclusion Criteria:

  • Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of < 25mmHg.
  • Use of other investigational drugs
  • Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve
  • History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation
  • Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580020

Locations
Germany
Novartis Investigative Site
Augsburg, Germany, 85155
Novartis Investigative Site
Bad Rothenfelde, Germany, 49215
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Berlin, Germany, 10713
Novartis Investigative Site
Bonn, Germany, 53127
Novartis Investigative Site
Bremen, Germany, 28209
Novartis Investigative Site
Chemnitz, Germany, 09116
Novartis Investigative Site
Darmstadt, Germany, 64298
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Düsseldorf, Germany, 40212
Novartis Investigative Site
Frankfurt, Germany, 60318
Novartis Investigative Site
Freiburg i. Br, Germany, 79106
Novartis Investigative Site
Glauchau, Germany, 08371
Novartis Investigative Site
Göttingen, Germany, 37075
Novartis Investigative Site
Halle, Germany, 06114
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Ingolstadt, Germany, 85049
Novartis Investigative Site
Karlsruhe, Germany, 76133
Novartis Investigative Site
Karlsruhe, Germany, 76199
Novartis Investigative Site
Koeln, Germany, 50935
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Ludwigshafen, Germany, 67063
Novartis Investigative Site
Marburg, Germany, 35039
Novartis Investigative Site
Minden, Germany, 32427
Novartis Investigative Site
Muelheim, Germany, 45468
Novartis Investigative Site
Muenster, Germany, 48145
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Munich, Germany, 80336
Novartis Investigative Site
München, Germany, 81675
Novartis Investigative Site
Recklinghausen, Germany, 45657
Novartis Investigative Site
Regensburg, Germany, 93042
Novartis Investigative Site
Sulzbach, Germany, 66280
Novartis Investigative Site
Tübingen, Germany, 72076
Novartis Investigative Site
Ulm, Germany, 89075
Novartis Investigative Site
Wolfsburg, Germany, 38442
Novartis Investigative Site
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01580020     History of Changes
Other Study ID Numbers: CRFB002EDE20
Study First Received: April 16, 2012
Last Updated: June 5, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Choroidal Neovascularization
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous ThrombosisSensation Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Vision, Low
Vision Disorders

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Anti-Inflammatory Agents
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014